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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Official Title

A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

Keywords

Mesothelioma Nivolumab Cisplatin Carboplatin Pemetrexed Antibodies, Monoclonal

Eligibility

For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Males and Females at least 18 years of age
  • Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
  • ECOG Performance status of 0 or 1
  • Available tumor sample for testing
  • Acceptable blood work

Exclusion Criteria:

  • Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
  • Prior chemotherapy for pleural mesothelioma
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
  • History of other malignancy unless the subject has been disease-free for at least 3 years
  • Active, untreated central nervous system (CNS) metastasis

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • Local Institution not yet accepting patients
    San Francisco, California, 94143, United States
  • Centro Estatal de Cancerologia accepting new patients
    Chihuahua, 31000, Mexico
  • Local Institution accepting new patients
    Df, Distrito Federal, 06720, Mexico
  • The University Of Texas MD Anderson Cancer Center accepting new patients
    Houston, Texas, 77030, United States
  • Local Institution accepting new patients
    Guadalajara, Jalisco, 44270, Mexico
  • Local Institution not yet accepting patients
    Rochester, Minnesota, 55905, United States
  • Medica Sur accepting new patients
    Mexico, Distrito Federal, 14050, Mexico
  • Local Institution not yet accepting patients
    Mexico, Distrito Federal, 14000, Mexico
  • University Of Chicago accepting new patients
    Chicago, Illinois, 60637, United States
  • Local Institution not yet accepting patients
    Nashville, Tennessee, 37203, United States
  • Cancer & Hematology Centers Of Western Michigan accepting new patients
    Grand Rapids, Michigan, 49503, United States
  • Barbara Ann Karmanos Cancer Center accepting new patients
    Detroit, Michigan, 48201, United States
  • Cleveland Clinic accepting new patients
    Cleveland, Ohio, 44195, United States
  • Allegheny Cancer Center accepting new patients
    Jefferson Hills, Pennsylvania, 15025, United States
  • West Virginia University accepting new patients
    Morgantown, West Virginia, 26506, United States
  • Local Institution not yet accepting patients
    Saint Petersburg, Florida, 33705, United States
  • H. Lee Moffitt Cancer Center & Research Inst, Inc accepting new patients
    Tampa, Florida, 33612, United States
  • Local Institution not yet accepting patients
    Fort Myers, Florida, 33901, United States
  • Univ Of Maryland Greenbaum Cancer Center accepting new patients
    Baltimore, Maryland, 21201, United States
  • University Of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Memorial Sloan Kettering Cancer Center accepting new patients
    New York, New York, 10065, United States
  • Yale University accepting new patients
    New Haven, Connecticut, 06520, United States
  • Administradora Del Country S.A. - Clinica Del Country accepting new patients
    Bogota, Colombia
  • Hospital Universitario San Ignacio accepting new patients
    Bogota, Colombia
  • Local Institution accepting new patients
    Moscow, 115478, Russian Federation
  • Local Institution accepting new patients
    Moscow, 121309, Russian Federation
  • Local Institution accepting new patients
    St.petersburg, 197758, Russian Federation
  • Local Institution accepting new patients
    Truro, Cornwall, TR1 3LJ, United Kingdom
  • Edinburgh Cancer Centre accepting new patients
    Edinburgh, Midlothian, EH4 2XU, United Kingdom
  • Local Institution accepting new patients
    Leicester, LE1 5WW, United Kingdom
  • Local Institution not yet accepting patients
    London, EC1A 7BE, United Kingdom
  • Local Institution accepting new patients
    Manchester, M23 9LT, United Kingdom
  • Local Institution accepting new patients
    Southampton, SO16 6YD, United Kingdom
  • Local Institution accepting new patients
    Nagoya-shi, Aichi, 4668560, Japan
  • Local Institution accepting new patients
    Chiba-shi, Chiba, 2608677, Japan
  • Local Institution accepting new patients
    Fukuyama-shi, Hiroshima, 7200001, Japan
  • Local Institution accepting new patients
    Hiroshima-Shi, Hiroshima, 7348551, Japan
  • Local Institution accepting new patients
    Sapporo-shi, Hokkaido, 0030804, Japan
  • Local Institution accepting new patients
    Amagasaki-shi, Hyogo, 6608550, Japan
  • Local Institution accepting new patients
    Nishinomiya-shi, Hyogo, 6638501, Japan
  • Local Institution accepting new patients
    Yokohama-shi, Kanagawa, 2408555, Japan
  • Local Institution accepting new patients
    Natori-shi, Miyagi, 9811293, Japan
  • Local Institution accepting new patients
    Niigata-shi, Niigata, 9518520, Japan
  • Local Institution accepting new patients
    Okayama-shi, Okayama, 7028055, Japan
  • Local Institution accepting new patients
    Kitaadachi-gun, Saitama, 3620806, Japan
  • Local Institution accepting new patients
    Chuo-ku, Tokyo, 1040045, Japan
  • Local Institution accepting new patients
    Ube-shi, Yamaguchi, 7550241, Japan
  • Local Institution accepting new patients
    Osakasayama-city, 5898511, Japan
  • Local Institution not yet accepting patients
    Porto Alegre, RIO Grande DO SUL, 90035-903, Brazil
  • Local Institution accepting new patients
    Barretos, SAO Paulo, 14784-400, Brazil
  • Local Institution not yet accepting patients
    Rio de Janeiro, 20230-130, Brazil
  • Local Institution accepting new patients
    Sao Paulo, 05403-010, Brazil
  • Local Institution accepting new patients
    Amsterdam, 1066 CX, Netherlands
  • Local Institution accepting new patients
    Rotterdam, 3015 CE, Netherlands
  • Local Institution accepting new patients
    Brussels, 1090, Belgium
  • Local Institution accepting new patients
    Edegem, 2650, Belgium
  • Local Institution accepting new patients
    Liege, 4000, Belgium
  • Local Institution accepting new patients
    Sint-Niklaas, 9100, Belgium
  • Local Institution accepting new patients
    Caen, 14000, France
  • Local Institution accepting new patients
    Creteil, 94010, France
  • Local Institution accepting new patients
    La Tronche, 38700, France
  • Local Institution accepting new patients
    Lille Cedex, 59037, France
  • Local Institution accepting new patients
    Marseille Cedex 20, 13915, France
  • Local Institution accepting new patients
    Paris, 75018, France
  • Local Institution accepting new patients
    Saint Herblain, 44805, France
  • Local Institution accepting new patients
    Strasbourg Cedex, 67091, France
  • Local Institution accepting new patients
    Toulon Cedex, 83056, France
  • Local Institution accepting new patients
    Toulouse Cedex 9, 31059, France
  • Local Institution not yet accepting patients
    Coswig, 01640, Germany
  • University Hospital Essen accepting new patients
    Essen, 45147, Germany
  • University Medicine Gottingen Germany accepting new patients
    Gottingen, 37075, Germany
  • Local Institution accepting new patients
    Grosshansdorf, 22927, Germany
  • Asklepios Klinik Harburg accepting new patients
    Hamburg, 21075, Germany
  • Thoraxklinik-Heidelberg Ggmbh accepting new patients
    Heidelberg, 69126, Germany
  • Universitaetsklinikum Des Saarlandes accepting new patients
    Homburg An D. Saar, 66421, Germany
  • Fachklinik Fuer Lungenkrankheiten accepting new patients
    Immenhausen, 34376, Germany
  • Kliniken Der Stadt Koeln Ggmbh Krankenhaus Mehrheim accepting new patients
    Koeln, 51109, Germany
  • Krankenhaus Bethanien Moers accepting new patients
    Moers, 47441, Germany
  • Centro Internacional de Estudios Clinicos accepting new patients
    Recoleta, Santiago DE Chile, Chile
  • Local Institution accepting new patients
    Bytom, 41-902, Poland
  • Local Institution accepting new patients
    Krakow, 31-202, Poland
  • Local Institution accepting new patients
    Warszawa, 02-781, Poland
  • Inselspital Bern accepting new patients
    Bern, 3010, Switzerland
  • Centre hospitalier universitaire Vaudois (CHUV) accepting new patients
    Lausanne, 1011, Switzerland
  • University Hospital Zurich accepting new patients
    Zurich, 8091, Switzerland
  • Centro Di Riferimento Oncologico accepting new patients
    Aviano, 33081, Italy
  • Local Institution accepting new patients
    Bari, 70124, Italy
  • Aou Policlinico V. Emanuele Di Catania accepting new patients
    Catania, 95124, Italy
  • Azienda Ospedaliera Universitaria S. Martino accepting new patients
    Genova, 16132, Italy
  • Local Institution accepting new patients
    Napoli, 80131, Italy
  • Local Institution accepting new patients
    Ravenna, 48121, Italy
  • Istituto Clinico Humanitas accepting new patients
    Rozzano, 20089, Italy
  • Azienda Ospedaliera Universitaria Senese accepting new patients
    Siena, 53100, Italy
  • Local Institution accepting new patients
    Bucharest, 020122, Romania
  • Local Institution accepting new patients
    Bucuresti, 021389, Romania
  • Local Institution accepting new patients
    Craiova, 200347, Romania
  • Local Institution accepting new patients
    Romania, 400015, Romania
  • Local Institution not yet accepting patients
    Beijing, Beijing, 100032, China
  • Local Institution not yet accepting patients
    Beijing, Beijing, 100142, China
  • Local Institution not yet accepting patients
    Haerbin, Heilongjiang, 150081, China
  • Local Institution not yet accepting patients
    Nanchang, Jiangxi, China
  • Local Institution not yet accepting patients
    Changchun, Jilin, 130012, China
  • Local Institution not yet accepting patients
    Changchun, Jilin, 130021, China
  • Local Institution not yet accepting patients
    Shenyang, Liaoning, China
  • Local Institution not yet accepting patients
    Xian, Shaanxi, 710038, China
  • Local Institution not yet accepting patients
    Shanghai, Shanghai, 200025, China
  • Local Institution not yet accepting patients
    Hanghzou, Zhejiang, China
  • Local Institution not yet accepting patients
    Hangzhou, Zhejiang, 310003, China
  • Local Institution not yet accepting patients
    Hangzhou, Zhejiang, 310022, China
  • Local Institution not yet accepting patients
    Wenzhou, Zhejiang, 325000, China
  • Local Institution not yet accepting patients
    Hangzhou, 310016, China
  • Local Institution not yet accepting patients
    Kunming, China
  • Local Institution not yet accepting patients
    Shanghai, 200030, China
  • Local Institution not yet accepting patients
    Shanghai, 200032, China
  • Local Institution accepting new patients
    Athens, 11527, Greece
  • Local Institution accepting new patients
    Thessaloniki, 57001, Greece
  • Local Institution not yet accepting patients
    Ankara, 06100, Turkey
  • Local Institution not yet accepting patients
    Ankara, 06100, Turkey
  • Local Institution accepting new patients
    Diyarbakır, 21280, Turkey
  • Local Institution accepting new patients
    Istanbul, 34098, Turkey
  • Local Institution accepting new patients
    Seyhan, 01130, Turkey
  • Concord Repatriation General Hospital accepting new patients
    Sydney, New South Wales, 2139, Australia
  • Local Institution accepting new patients
    Birtinya, Queensland, 4575, Australia
  • Monash Medical Centre Clayton accepting new patients
    Clayton, Victoria, 3168, Australia
  • Cabrini Hospital accepting new patients
    Malvern, Victoria, 3144, Australia
  • Local Institution accepting new patients
    Nedlands, Western Australia, 6009, Australia
  • Local Institution accepting new patients
    Johannesburg, Gauteng, 2196, South Africa
  • Local Institution accepting new patients
    Pretoria, Gauteng, 0075, South Africa
  • Local Institution accepting new patients
    Cape Town, Western CAPE, 7570, South Africa

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT02899299
Phase
Phase 3
Lead Scientist
Thierry Jahan
Study Type
Interventional
Last Updated
November 6, 2017
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